1Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
Inspection Record
Acme Generics Pvt. Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
3Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
4Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The maintenance of records was inadequate.
5Other quality system
The recorded information or details were inadequate.
6Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
7Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
8Laboratory and QC controls
The receipt, preparation, and/or handling of reagents and culture media was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
9Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
10Equipment and facility
The design, construction, operation, and/or location of the equipment was inadequate for preventing contamination of the drug.
11Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
12Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-02-03. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
